Testing a probiotic's effect on immune function

Acute Immune Modulation by Probiotic Strain Bacillus Coagulans JBI-YZ6.3 (BC4U)

This study is testing whether different doses of a probiotic can boost the immune system in healthy adults compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Natural Immune Systems Inc (Academic / other)
• Locations: 1 site (Klamath Falls, Oregon)
• Trial ID: NCT06754228 on ClinicalTrials.gov

What this trial studies

This clinical proof-of-concept study evaluates the acute immune effects of three different doses of the probiotic strain Bacillus coagulans JBI-YZ6.3 compared to a placebo. Twenty-four healthy adult participants will undergo a placebo-controlled, escalating dose, cross-over design, with each dose separated by a one-week washout period. Blood samples will be collected at various intervals after administration to assess immune status and cytokine levels, aiming to determine the probiotic's impact on immune function.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 75 who can comply with the study's dietary and lifestyle restrictions.

Not a fit: Patients with a history of major gastrointestinal surgery or those taking daily anti-inflammatory medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how probiotics can modulate immune responses, potentially leading to new therapeutic strategies.

How similar studies have performed: While the specific probiotic strain may be novel, similar studies have shown promising results in using probiotics for immune modulation.

Eligibility criteria

Inclusion Criteria:

* Healthy adults;
* Age 18-75 years (inclusive);
* Veins easy to see in one or both arms (to allow for the multiple blood draws);
* Willing to comply with study procedures, including:

  * Maintaining a consistent diet and lifestyle routine throughout the study,
  * Consistent habit of bland breakfasts on days of clinic visits,
  * Abstaining from exercising and nutritional supplements on the morning of a study visit,
  * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
  * Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
* Taking anti-inflammatory medications on a daily basis;
* Currently experiencing intense stressful events/ life changes;
* Currently in intensive athletic training (such as marathon runners);
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Anxiety about having blood drawn;
* Pregnant, nursing, or trying to become pregnant;
* Known food allergies related to ingredients in active test product or placebo.

Where this trial is running

Klamath Falls, Oregon

• NIS Labs — Klamath Falls, Oregon, United States (Recruiting)

Conditions Immune Surveillance